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Trial record 34 of 267 for:    Pancreatic Cancer AND Resectable

Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT02347618
Recruitment Status : Active, not recruiting
First Posted : January 27, 2015
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Alan Katz, University of Rochester

Brief Summary:
The purpose of this study is to determine whether a short-course of stereotactic body radiotherapy (SBRT) prior to surgical resection of pancreatic adenocarcinoma is feasible and well-tolerated.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Adenocarcinoma Radiation: Preoperative SBRT Not Applicable

Detailed Description:
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Short-Course Preoperative Stereotactic Body Radiation Therapy for Resectable Pancreatic Cancer
Study Start Date : December 2014
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Preoperative SBRT
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
Radiation: Preoperative SBRT
This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.




Primary Outcome Measures :
  1. Incidence of grade 2 or greater toxicity [ Time Frame: 2 years ]
    Number of incidence of grade 2 or greater toxicity


Secondary Outcome Measures :
  1. Number of Participants with no further growth of cancer at original site (Local control) [ Time Frame: 2 years ]
    Count subjects with no further growth of cancer at original site.

  2. Count subjects with Recurrence of cancer in other body sites [ Time Frame: 2 years ]
    Compare recurrence locations of treated patients relative to historical controls.

  3. Time to Progression of pancreatic cancer [ Time Frame: 4 years ]
    Duration of progression free survival of treated patients

  4. Time to death [ Time Frame: 4 years ]
    Measure duration of survival of treated patients.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient with pathologically proven diagnosis of adenocarcinoma of the head of the pancreas
  2. CT w/ contrast using the pancreas protocol or MRI of the abdomen with contrast within 6 weeks prior to registration
  3. CT chest or PET/CT within 6 weeks prior to registration
  4. Clinically determined to be resectable based on NCCN Criteria:
  5. No radiographic evidence of superior mesenteric vein or portal vein distortion
  6. No evidence of distant metastasis
  7. Clear fat planes around the celiac axis, hepatic artery, and superior mesenteric artery
  8. No enlarged lymph nodes per CT criteria or PET avid lymph nodes
  9. No lymphadenopathy outside the surgical field (i.e. celiac or para-aortic adenopathy)
  10. Adequate cardiopulmonary reserves to tolerate surgery
  11. Karnofsky performance status > 70
  12. Age >18
  13. Adequate bone marrow function defined as follows:
  14. Absolute neutrophil count (ANC) > 1800 cells/mm3
  15. Platelets ≥ 100,000 cells/mm3
  16. Hemoglobin > 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb > 8 g/dl is acceptable.)
  17. Pregnancy test must be negative for women of childbearing potential within 7 days prior to study entry
  18. Patient must sign study specific informed consent prior to study entry

Exclusion Criteria:

  1. Prior surgical resection of any pancreatic malignancy
  2. Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
  3. Any prior chemotherapy or radiation for treatment of the patient's pancreatic tumor.
  4. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  5. Severe, active comorbidity, defined as follows:

    1. Unstable angina and/or congestive heart failure requiring hospitalization within the last 12 months
    2. Transmural myocardial infarction within the last 6 months
    3. Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to registration.
  6. Severe, uncorrectable hepatic insufficiency and/or coagulation defects due to liver failure
  7. Any evidence of distant metastases (M1)
  8. Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02347618


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Alan W Katz, MD MPH University of Rochester

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Responsible Party: Alan Katz, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT02347618     History of Changes
Other Study ID Numbers: UGUP14107
First Posted: January 27, 2015    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Pancreatic Diseases
Adenocarcinoma
Carcinoma
Digestive System Diseases
Endocrine System Diseases